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    <tradeName>06973642381049</tradeName>
    <deviceName>Tigsun VVC/TV/GV Combo Antigen Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:22:52.611Z</lastUpdated>
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    <udiDi>06973642381032</udiDi>
    <basicUdiDi>B-06973642381032</basicUdiDi>
    <tradeName>06973642381032</tradeName>
    <deviceName>Tigsun VVC/TV/GV Combo Antigen Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
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    <udiDi>06973642381056</udiDi>
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    <tradeName>06973642381056</tradeName>
    <deviceName>Tigsun VVC/TV/GV Combo Antigen Test</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <deviceName>Tigsun COVID-19 Saliva Antigen Rapid Test (LolliSwab)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:22:35.747Z</lastUpdated>
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    <udiDi>06973642380011</udiDi>
    <basicUdiDi>B-06973642380011</basicUdiDi>
    <tradeName>06973642380011</tradeName>
    <deviceName>Tigsun COVID-19 Saliva Antigen Rapid Test (LolliSwab)</deviceName>
    <manufacturerName>Beijing Tigsun Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034480</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:22:33.348Z</lastUpdated>
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    <udiDi>06972719600991</udiDi>
    <basicUdiDi>B-06972719600991</basicUdiDi>
    <tradeName>06972719600991</tradeName>
    <deviceName>SARS-CoV-2 Neutralizing Antibody Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>215740003</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:33:59.290Z</lastUpdated>
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    <basicUdiDi>B-06971792053410</basicUdiDi>
    <tradeName>Dengue NS1 Antigen (DEN NS1 Ag) Assay Reagent Kit (CMIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>DENGUE VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C2KJ002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:56:37.634Z</lastUpdated>
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    <basicUdiDi>B-06971792053304</basicUdiDi>
    <tradeName>Influenza A&amp;B Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040604</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K251316T</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:56:32.484Z</lastUpdated>
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    <udiDi>06971792053069</udiDi>
    <basicUdiDi>B-06971792053069</basicUdiDi>
    <tradeName>RSV Rapid Test Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040605</emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K311416D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:56:19.559Z</lastUpdated>
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    <udiDi>06971792050884</udiDi>
    <basicUdiDi>B-06971792050884</basicUdiDi>
    <tradeName>Human Monkeypox Virus (MPV) Antigen Rapid Test Device (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K771616D</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:53:01.143Z</lastUpdated>
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    <udiDi>06971792050853</udiDi>
    <basicUdiDi>B-06971792050853</basicUdiDi>
    <tradeName>Human Monkeypox Virus (MPV) IgG/IgM Antibody Rapid Test Device(Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K760216D</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:52:59.250Z</lastUpdated>
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    <udiDi>06971792050822</udiDi>
    <basicUdiDi>B-06971792050822</basicUdiDi>
    <tradeName>2-IN-1 COVID-19 Antigen Rapid Test Device (swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K791416D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:52:56.783Z</lastUpdated>
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    <basicUdiDi>B-06971792050761</basicUdiDi>
    <tradeName>SARS-Cov-2＆ FLU A&amp;B &amp; RSV &amp; Adv Combo  Rapid Test Cassette (swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>K551416D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:52:55.182Z</lastUpdated>
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    <udiDi>06971792050723</udiDi>
    <basicUdiDi>B-06971792050723</basicUdiDi>
    <tradeName>One Step Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test(Oral Fluid)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>K740516D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:52:54.385Z</lastUpdated>
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    <basicUdiDi>B-06971792050792</basicUdiDi>
    <tradeName>2-IN-1 COVID-19 Antigen Rapid Test Device（Nasal&amp;Saliva）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <reference>K711616D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:52:53.038Z</lastUpdated>
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    <basicUdiDi>B-06971792050686</basicUdiDi>
    <tradeName>Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test(Oral Fluid)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K730516D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:52:39.128Z</lastUpdated>
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    <basicUdiDi>B-06971792050655</basicUdiDi>
    <tradeName>Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (nasal swab)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K721416D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:52:35.112Z</lastUpdated>
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    <basicUdiDi>B-06971792050624</basicUdiDi>
    <tradeName>Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (saliva)</tradeName>
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    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K700516D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:52:34.306Z</lastUpdated>
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    <basicUdiDi>B-06971792050532</basicUdiDi>
    <tradeName>2019-nCOV IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K460216D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:52:33.524Z</lastUpdated>
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    <basicUdiDi>B-06971792050525</basicUdiDi>
    <tradeName>Novel Coronavirus （COVID-19）Neutralizing Antibody Rapid Test Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K660216D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:52:32.711Z</lastUpdated>
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